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Health BehaviorNCT03450382

Hans Kai: Impact of a Peer Lead Community Health Program on Behavior Change, Mental Health, Health Efficacy and Social Support Comparative Control Study

A study testing Hans Kai Education in people with Health Behavior, run by NorWest Co-op Community Health at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To study the difference between participants interested in a lifestyle change when enrolled in Hans Kai or not when comparing behaviour change, social support, self health efficacy and mental health. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Health Behavior
What is being tested?
Hans Kai Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
1 Apr 2018to 30 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • cognitively impaired
  • Under 18
  • students of children of Research team
  • clients in emergency/life threatening conditions

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Access NorWest

    Winnipeg, Manitoba, R2X 3B9

Other trials in Canada

About this study

To study the difference between participants interested in a lifestyle change when enrolled in Hans Kai or not when comparing behaviour change, social support, self health efficacy and mental health. Hans Kai is a community based, peer led program that is low cost and self sustaining, which places participants through a 9 week health school to learn skills related to improving health such as nutrition, exercise, sleep, stress management etc. Once completed, participants form a Hans Kai group and continue meeting independently of health care providers

Read the detailed description

Research Question Does Hans Kai have a greater influence on healthy behavior change, mental health status, social connectedness, and self-health efficacy outcomes compared to community healthcare clients with access to health education programming.

Hypothesis - Hans Kai members will experience higher mental health improvement scores compared to control group.

Hans Kai members will experience greater social connectedness compared to control group.

Hans Kai members will experience greater self-health efficacy compared to control group.

Hans Kai members will adopt more behavior changes compared to control group.

Null Hypothesis - There is no significant difference between Hans Kai members and control group in terms of mental health improvement scores.

There is no significant difference between Hans Kai members and control group in terms of social connectedness scores.

There is no significant difference between Hans Kai members and control group in terms of self-health efficacy scores.

There is no significant difference between Hans Kai members and control group in terms of adopted behavior change numbers.

In order to meet the demand for health programming in and reduce the prevalence of chronic disease NorWest developed the HANS KAI Project. Hans Kai is a self-sustaining, participant led health program for individuals wanting to maintain or improve their health. Hans Kai groups consist of 8-40 people per group in communities or workplaces. Hans Kai empowers individuals to take control of their own health and provides a unique opportunity for participants to have an active role in improving or maintaining their own health and well-being and that of their community.

HANS Kai Focuses on a number of factors relating to health including:

Healthy eating, physical activity, managing sleep and stress, mental health, physical health indicators, leadership and social supports. The program is participant led which enables members to have an active role in their health and the health of their families and communities.

Currently NorWest has trained 37 people in 5 provinces across Canada to deliver HANS KAI in their community and demand is growing. NorWest has developed a Teen and Family HANS KAI to address health across the ages.

HANS KAI's initial research phase assessed roughly 60 participants over 2 years to determine the impact of Hans Kai on strategic health indictors and influences. Our research and evaluation showed statistically significant improvements in:

Mental Health (prior to HANS Kai 33% had Flourishing Mental Health at 12 months 69% had Flourishing Mental Health) Physical Activity Knowledge of Health Connection to Resources Increased Social Connections, and Upward trends in nutrition. As the program continued to evolve, community members and participants were involved in every phase, giving community feedback on important health related topics they wanted discussed and to be given more information on. This lead the researchers toward the second phase of research which now focuses heavily on behavior change. Putting into practice the information that participants learn was the highest feedback received, and this echoes trends in health promotion interventions, as preventative healthcare and integrated service becomes the pinnacle to healthy communities. Empowering people and building their resilience is dependent on needs and perceived value of different lifestyle influences. For instance, an economically disadvantaged family may struggle on a low income, but may find value in the Hans Kai nutrition classes on how to feed their family healthy options and recipes on a fixed budget. Addressing a change from eating take-out to home cooking helps to move this family towards better health and become economically stronger through education and application. Building on this scenario, Hans Kai also serves to bolster social engagement, drawing out isolated individuals to engage in their communities, increasing their mental health and well-being. The researchers strive to prove that this support carries over into the overall lifestyle, increasing the likelihood and motivation to improve physical activity levels with other group members interested in the same. This increase in self-efficacy promotes community and family leadership, as others see positive life choices, they are likely to join in, seeing family walks become routine and volunteering in community engagement on the rise.

The researchers are wanting to prove that community led health programs lead to health behaviour changes in healthy lifestyle choices with social support and self-efficacy.

After completing our first phase of research, the researchers were able to determine challenges and how to improve them as research heads into the second phase. Creating group champions to help collect interval research data and modifying our research to determine a power difference between a control and Hans Kai member was of the utmost importance. The research objectives will be looking to discover the differences between non Hans Kai community members and Hans Kai members in the areas of: self-efficacy, behavior change, physical activity, nutrition, mental health and community connectedness. Data comparisons from initial baselines without the Hans Kai intervention, followed by a 9 week survey after Hans Kai participants have completed the health school, followed by a 6 month and one year survey will be assessed. The purpose in completing these objectives is to determine whether the Hans Kai model produces better results in each of the mentioned areas for participants interested in a lifestyle change compared to those participants not introduced to the Hans Kai concept of education. If successful, the Hans Kai model will be further studied and promoted to more community health clinics as a low cost method to produce positive healthy behaviours to communities.

Conditions
Health Behavior
Being tested
Hans Kai Education
Keywords
community health, mental health, behavior change, social support, health promotion
Medical subject headings
Health Behavior, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hans Kai EducationOther

    9 weeks of health education classes preceding social group formation into Hans Kai. Peer led support focused on behavioural change.

Study groups in NCT03450382
Study groupRoleWhat they receive
Hans Kai ParticipantExperimentalParticipants receiving Hans Kai intervention
Receives: Other: Hans Kai Education
ControlNo interventionParticipants not enrolled in Hans Kai

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Behaviour Change

    To determine the power difference between Hans Kai participants and control group with respect to behavior change. Readiness to Change, Confidence to Change Questionnaire: Gillespie \& Lenz (2011) will be used to measure this outcome.

    Measured: 1 year

  2. Self-health Efficacy

    To determine the power difference between Hans Kai participants and control group with respect to self-health efficacy. Health Self-Efficacy Questionnaire: Lee, Hwang, Hawkins \& Pingree (2008) will be used to measure this outcome.

    Measured: 1 year

  3. Social Support

    To determine the power difference between Hans Kai participants and control group with respect to Social Support. A Social Connectedness Questionnaire developed by researchers will be used to measure this outcome.

    Measured: 1 year

  4. Mental Health

    To determine the power difference between Hans Kai participants and control group with respect to mental health. Mental Health Questionnaire: Keyes, C.L.M. (2009) will be used to measure this outcome.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2018
  2. Study start1 Apr 2018 (estimated)
  3. Primary completion1 Jun 2020 (estimated)
  4. Study completion30 Jun 2020 (estimated)

Why it stopped: New Principal Investigator

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Crossover
Model description
Open label, quasi-experimental clinical trial comparative study.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03450382
Sponsor's protocol ID
02222018
Status last verified
Feb 2018
First submitted
22 Feb 2018
Last updated
28 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared with other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing Hans Kai Education in people with Health Behavior, run by NorWest Co-op Community Health at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Behaviour Change (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.

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